Interferon Alpha-2B Proven To Be The First Effective Drug Treatment For Malignant Melanoma

PITTSBURGH, April 27, 2001 — A study released today in the Journal of Clinical Oncology (JCO), conducted by the Eastern Oncology Cooperative Group (ECOG), a group of 22 academic institutions and more than 300 community hospitals, led by University of Pittsburgh Cancer Institute (UPCI) researcher John M. Kirkwood, M.D., establishes interferon alpha-2b (INTRON™ A) as the first and only effective adjuvant therapy for high-risk melanoma patients, dramatically increasing relapse-free and overall survival rates. Without this drug therapy, which is given after surgery, patients have a one and one-half times greater chance of relapse and death.

“This report confirms our earlier evidence that interferon alpha-2b should be the standard adjuvant therapy for high-risk melanoma patients,” said Dr. Kirkwood, professor and vice chairman of research, health sciences, University of Pittsburgh and director of the UPCI Melanoma Center. “If physicians aggressively treat melanoma patients with this regimen, the epidemic number of deaths from this type of cancer will be reduced.”

Melanoma is the most life-threatening type of skin cancer, causing nearly 8,000 deaths each year in the United States; during the last 20 years, the incidence rate has doubled. Malignant melanoma is the number one cancer-related cause of death in Americans age 25-30. High-risk patients have a 50 to 80 percent chance of disease recurrence without this treatment. Once melanoma recurs, it is more difficult to treat.

INTRON-A™ was approved for the treatment of melanoma in 1995 based on studies detailing the impact on relapse-free and overall survival rates. Subsequent trials showed that interferon alpha-2b (IFN a-2b), increased relapse-free survival, but were unable to confirm that the drug positively affected overall survival. The study results released today confirm the drug’s effectiveness on overall survival rates and removes doubts about its use in high-risk patients, according to Dr. Kirkwood.

The current study, published in the May 1 edition of JCO, was funded by the National Cancer Institute (NCI) and ran from 1996 to 1999. It compared the relapse-free and overall survival rates of 880 surgically treated, high-risk melanoma patients who were either given IFN a-2b or GMK, a vaccine. Patients considered at high-risk are those with primary tumors that were greater than 4mm in depth or who had melanoma that spread to the lymph nodes. Patients were randomized to either receive IFN a-2b by intravenous infusion five days a week for four weeks, followed by subcutaneous injections three times a week for 48 weeks, or to receive the GMK vaccine given weekly for one month, then at three-month intervals for two years.

Dr. Kirkwood and his colleagues found that when treated with high doses of IFN a-2b, the likelihood that patients would relapse and die was reduced by 33 percent. The vaccine had no effect on the course of the disease.

Because of interim findings that showed compelling evidence that IFN a-2b was significantly superior to GMK, the trial was closed in April 2000. Dr. Kirkwood’s article in JCO provides the full, final analysis of the impact of this trial.

The results of this study have paved the way for new trials testing the effectiveness of IFN a-2b in the treatment of less severe melanoma, using the drug for a shorter period of time and combining it with other agents. UPCI, as a member of ECOG and the Southwest Oncology Group (SWOG), is leading these studies.

For more information about this and other studies, call UPCI’s Cancer Information and Referral Service at 1-800-237-4PCI.

Ranked 12th in NCI funding and the only NCI-designated comprehensive cancer center in western Pennsylvania, UPCI is widely recognized as a leader in translating laboratory findings into applications of clinical importance and for its commitment to developing new and effective approaches to cancer prevention, diagnosis, treatment and care.

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